ÖNORM EN 12306

This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and Users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms. This standard does not apply to diagnostic kits used either in food industry or for human health monitoring, or control of non biological contaminants. This European Standard does not concem single kit components such as reagents (i.e. monoclonal or polyclonal antibodies) or materials (i.e. ELISA plate). This standard does not concern any specific diagnostic method (such as ELISA, Dot blot, DNA probe). This European Standard does not aim to establish a system of quality assurance but it is recommended that quality control procedures are in accordance with a system of quality assurance such as EN ISO 9000 series.